CN111067876A - α -linolenic acid double-layer tablet and preparation method thereof - Google Patents
α -linolenic acid double-layer tablet and preparation method thereof Download PDFInfo
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- CN111067876A CN111067876A CN201911224796.8A CN201911224796A CN111067876A CN 111067876 A CN111067876 A CN 111067876A CN 201911224796 A CN201911224796 A CN 201911224796A CN 111067876 A CN111067876 A CN 111067876A
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- layer
- inner layer
- linolenic acid
- outer layer
- lubricant
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- DTOSIQBPPRVQHS-PDBXOOCHSA-N alpha-linolenic acid Chemical compound CC\C=C/C\C=C/C\C=C/CCCCCCCC(O)=O DTOSIQBPPRVQHS-PDBXOOCHSA-N 0.000 title claims abstract description 149
- 235000020661 alpha-linolenic acid Nutrition 0.000 title claims abstract description 77
- 229960004488 linolenic acid Drugs 0.000 title claims abstract description 77
- 238000002360 preparation method Methods 0.000 title claims abstract description 13
- 239000000945 filler Substances 0.000 claims abstract description 32
- 239000000314 lubricant Substances 0.000 claims abstract description 30
- 239000000853 adhesive Substances 0.000 claims abstract description 24
- 230000001070 adhesive effect Effects 0.000 claims abstract description 24
- 239000002250 absorbent Substances 0.000 claims abstract description 15
- 230000002745 absorbent Effects 0.000 claims abstract description 15
- 239000007884 disintegrant Substances 0.000 claims abstract description 9
- 238000000034 method Methods 0.000 claims abstract description 8
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical group [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 claims description 64
- 239000008187 granular material Substances 0.000 claims description 44
- 238000002156 mixing Methods 0.000 claims description 40
- DBMJMQXJHONAFJ-UHFFFAOYSA-M Sodium laurylsulphate Chemical compound [Na+].CCCCCCCCCCCCOS([O-])(=O)=O DBMJMQXJHONAFJ-UHFFFAOYSA-M 0.000 claims description 32
- 229920002472 Starch Polymers 0.000 claims description 32
- 235000019359 magnesium stearate Nutrition 0.000 claims description 32
- 235000013809 polyvinylpolypyrrolidone Nutrition 0.000 claims description 32
- 229920000523 polyvinylpolypyrrolidone Polymers 0.000 claims description 32
- 235000019333 sodium laurylsulphate Nutrition 0.000 claims description 32
- 239000008107 starch Substances 0.000 claims description 32
- 235000019698 starch Nutrition 0.000 claims description 32
- 238000001035 drying Methods 0.000 claims description 30
- LYCAIKOWRPUZTN-UHFFFAOYSA-N Ethylene glycol Chemical compound OCCO LYCAIKOWRPUZTN-UHFFFAOYSA-N 0.000 claims description 28
- 229920001030 Polyethylene Glycol 4000 Polymers 0.000 claims description 28
- 229920000881 Modified starch Polymers 0.000 claims description 27
- WHNWPMSKXPGLAX-UHFFFAOYSA-N N-Vinyl-2-pyrrolidone Chemical group C=CN1CCCC1=O WHNWPMSKXPGLAX-UHFFFAOYSA-N 0.000 claims description 26
- 229960000913 crospovidone Drugs 0.000 claims description 26
- 239000002002 slurry Substances 0.000 claims description 26
- 239000002994 raw material Substances 0.000 claims description 23
- 229920000168 Microcrystalline cellulose Polymers 0.000 claims description 22
- 235000019813 microcrystalline cellulose Nutrition 0.000 claims description 22
- 239000008108 microcrystalline cellulose Substances 0.000 claims description 22
- 229940016286 microcrystalline cellulose Drugs 0.000 claims description 22
- 239000003795 chemical substances by application Substances 0.000 claims description 21
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Substances O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims description 20
- 235000004426 flaxseed Nutrition 0.000 claims description 19
- 239000007864 aqueous solution Substances 0.000 claims description 18
- GUBGYTABKSRVRQ-QKKXKWKRSA-N lactose group Chemical group OC1[C@H](O)[C@@H](O)[C@H](O[C@H]2[C@H](O)[C@@H](O)[C@@H](O)[C@H](O2)CO)[C@H](O1)CO GUBGYTABKSRVRQ-QKKXKWKRSA-N 0.000 claims description 18
- MJYQFWSXKFLTAY-OVEQLNGDSA-N (2r,3r)-2,3-bis[(4-hydroxy-3-methoxyphenyl)methyl]butane-1,4-diol;(2r,3r,4s,5s,6r)-6-(hydroxymethyl)oxane-2,3,4,5-tetrol Chemical compound OC[C@H]1O[C@@H](O)[C@H](O)[C@@H](O)[C@@H]1O.C1=C(O)C(OC)=CC(C[C@@H](CO)[C@H](CO)CC=2C=C(OC)C(O)=CC=2)=C1 MJYQFWSXKFLTAY-OVEQLNGDSA-N 0.000 claims description 16
- FBPFZTCFMRRESA-KVTDHHQDSA-N D-Mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO FBPFZTCFMRRESA-KVTDHHQDSA-N 0.000 claims description 16
- 239000004375 Dextrin Substances 0.000 claims description 16
- 229920001353 Dextrin Polymers 0.000 claims description 16
- 229930195725 Mannitol Natural products 0.000 claims description 16
- 235000019425 dextrin Nutrition 0.000 claims description 16
- 239000008101 lactose Substances 0.000 claims description 16
- 239000000594 mannitol Substances 0.000 claims description 16
- 235000010355 mannitol Nutrition 0.000 claims description 16
- 239000002245 particle Substances 0.000 claims description 13
- XAAHAAMILDNBPS-UHFFFAOYSA-L calcium hydrogenphosphate dihydrate Chemical group O.O.[Ca+2].OP([O-])([O-])=O XAAHAAMILDNBPS-UHFFFAOYSA-L 0.000 claims description 12
- 235000019700 dicalcium phosphate Nutrition 0.000 claims description 12
- 239000007779 soft material Substances 0.000 claims description 12
- 238000000227 grinding Methods 0.000 claims description 10
- 238000010298 pulverizing process Methods 0.000 claims description 10
- 238000007873 sieving Methods 0.000 claims description 10
- 239000011230 binding agent Substances 0.000 claims description 8
- 229920000591 gum Polymers 0.000 claims description 7
- 238000005303 weighing Methods 0.000 claims description 7
- 239000000203 mixture Substances 0.000 claims description 6
- 241000208202 Linaceae Species 0.000 claims description 5
- 235000004431 Linum usitatissimum Nutrition 0.000 claims description 5
- 238000009835 boiling Methods 0.000 claims description 5
- 239000012153 distilled water Substances 0.000 claims description 5
- 238000003756 stirring Methods 0.000 claims description 2
- 230000000694 effects Effects 0.000 abstract description 6
- 230000008569 process Effects 0.000 abstract description 4
- 238000001727 in vivo Methods 0.000 abstract description 3
- 239000003814 drug Substances 0.000 abstract description 2
- 229940032147 starch Drugs 0.000 description 28
- OYPRJOBELJOOCE-UHFFFAOYSA-N Calcium Chemical compound [Ca] OYPRJOBELJOOCE-UHFFFAOYSA-N 0.000 description 8
- 229910052791 calcium Inorganic materials 0.000 description 8
- 239000011575 calcium Substances 0.000 description 8
- 229960005069 calcium Drugs 0.000 description 8
- 150000004683 dihydrates Chemical class 0.000 description 8
- 241000282414 Homo sapiens Species 0.000 description 6
- 239000001253 polyvinylpolypyrrolidone Substances 0.000 description 6
- 238000012360 testing method Methods 0.000 description 6
- KQQKGWQCNNTQJW-UHFFFAOYSA-N linolenic acid Natural products CC=CCCC=CCC=CCCCCCCCC(O)=O KQQKGWQCNNTQJW-UHFFFAOYSA-N 0.000 description 5
- 239000000243 solution Substances 0.000 description 5
- 239000000047 product Substances 0.000 description 4
- 229910052782 aluminium Inorganic materials 0.000 description 3
- XAGFODPZIPBFFR-UHFFFAOYSA-N aluminium Chemical compound [Al] XAGFODPZIPBFFR-UHFFFAOYSA-N 0.000 description 3
- 238000011161 development Methods 0.000 description 3
- 230000018109 developmental process Effects 0.000 description 3
- FPAFDBFIGPHWGO-UHFFFAOYSA-N dioxosilane;oxomagnesium;hydrate Chemical compound O.[Mg]=O.[Mg]=O.[Mg]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O.O=[Si]=O FPAFDBFIGPHWGO-UHFFFAOYSA-N 0.000 description 3
- 238000002474 experimental method Methods 0.000 description 3
- 239000011888 foil Substances 0.000 description 3
- 235000021388 linseed oil Nutrition 0.000 description 3
- 239000000944 linseed oil Substances 0.000 description 3
- 239000003921 oil Substances 0.000 description 3
- 235000019198 oils Nutrition 0.000 description 3
- 206010028980 Neoplasm Diseases 0.000 description 2
- 230000008901 benefit Effects 0.000 description 2
- 230000036772 blood pressure Effects 0.000 description 2
- 210000004556 brain Anatomy 0.000 description 2
- 235000001465 calcium Nutrition 0.000 description 2
- 201000011510 cancer Diseases 0.000 description 2
- 230000036541 health Effects 0.000 description 2
- 238000005286 illumination Methods 0.000 description 2
- 235000016709 nutrition Nutrition 0.000 description 2
- 235000020777 polyunsaturated fatty acids Nutrition 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- AQQWWUIGQFJCMJ-OQQRQXPPSA-N (9z,12z,15z)-octadeca-9,12,15-trienoic acid Chemical compound CC\C=C/C\C=C/C\C=C/CCCCCCCC(O)=O.CC\C=C/C\C=C/C\C=C/CCCCCCCC(O)=O AQQWWUIGQFJCMJ-OQQRQXPPSA-N 0.000 description 1
- 208000000044 Amnesia Diseases 0.000 description 1
- 208000031091 Amnestic disease Diseases 0.000 description 1
- 208000024172 Cardiovascular disease Diseases 0.000 description 1
- 241000196324 Embryophyta Species 0.000 description 1
- 206010020772 Hypertension Diseases 0.000 description 1
- 238000010521 absorption reaction Methods 0.000 description 1
- 230000006986 amnesia Effects 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 230000009286 beneficial effect Effects 0.000 description 1
- 239000008280 blood Substances 0.000 description 1
- 210000004369 blood Anatomy 0.000 description 1
- 230000004641 brain development Effects 0.000 description 1
- 208000026106 cerebrovascular disease Diseases 0.000 description 1
- 230000019771 cognition Effects 0.000 description 1
- 230000007812 deficiency Effects 0.000 description 1
- 238000001514 detection method Methods 0.000 description 1
- 206010012601 diabetes mellitus Diseases 0.000 description 1
- 235000014113 dietary fatty acids Nutrition 0.000 description 1
- 235000006694 eating habits Nutrition 0.000 description 1
- 230000002526 effect on cardiovascular system Effects 0.000 description 1
- 235000004626 essential fatty acids Nutrition 0.000 description 1
- 238000000605 extraction Methods 0.000 description 1
- 201000005577 familial hyperlipidemia Diseases 0.000 description 1
- 235000019197 fats Nutrition 0.000 description 1
- 239000000194 fatty acid Substances 0.000 description 1
- 229930195729 fatty acid Natural products 0.000 description 1
- 150000004665 fatty acids Chemical class 0.000 description 1
- 235000013305 food Nutrition 0.000 description 1
- 230000006870 function Effects 0.000 description 1
- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
- 229910052737 gold Inorganic materials 0.000 description 1
- 229910001385 heavy metal Inorganic materials 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 238000012986 modification Methods 0.000 description 1
- 230000004048 modification Effects 0.000 description 1
- 235000020660 omega-3 fatty acid Nutrition 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000001335 perilla frutescens leaf extract Substances 0.000 description 1
- 238000011160 research Methods 0.000 description 1
- 230000033764 rhythmic process Effects 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 239000013589 supplement Substances 0.000 description 1
- 208000024891 symptom Diseases 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/185—Acids; Anhydrides, halides or salts thereof, e.g. sulfur acids, imidic, hydrazonic or hydroximic acids
- A61K31/19—Carboxylic acids, e.g. valproic acid
- A61K31/20—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids
- A61K31/202—Carboxylic acids, e.g. valproic acid having a carboxyl group bound to a chain of seven or more carbon atoms, e.g. stearic, palmitic, arachidic acids having three or more double bonds, e.g. linolenic
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2009—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2013—Organic compounds, e.g. phospholipids, fats
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2054—Cellulose; Cellulose derivatives, e.g. hydroxypropyl methylcellulose
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2004—Excipients; Inactive ingredients
- A61K9/2022—Organic macromolecular compounds
- A61K9/205—Polysaccharides, e.g. alginate, gums; Cyclodextrin
- A61K9/2059—Starch, including chemically or physically modified derivatives; Amylose; Amylopectin; Dextrin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/20—Pills, tablets, discs, rods
- A61K9/2072—Pills, tablets, discs, rods characterised by shape, structure or size; Tablets with holes, special break lines or identification marks; Partially coated tablets; Disintegrating flat shaped forms
- A61K9/2086—Layered tablets, e.g. bilayer tablets; Tablets of the type inert core-active coat
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
- A61P25/28—Drugs for disorders of the nervous system for treating neurodegenerative disorders of the central nervous system, e.g. nootropic agents, cognition enhancers, drugs for treating Alzheimer's disease or other forms of dementia
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P35/00—Antineoplastic agents
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P39/00—General protective or antinoxious agents
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- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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Abstract
The invention belongs to the technical field of α -linolenic acid preparation, and particularly relates to a α -linolenic acid double-layer tablet and a preparation method thereof, wherein the tablet comprises an inner layer and an outer layer, the inner layer comprises an inner layer filler, an inner layer disintegrant, an inner layer adhesive, an inner layer lubricant and an inner layer absorbent, the outer layer comprises an outer layer filler, an outer layer disintegrant, an outer layer adhesive and an outer layer lubricant, and the preparation of the α -linolenic acid double-layer tablet adopts a method of wrapping the α -linolenic acid-containing inner layer by the outer layer, so that the stability of α -linolenic acid is improved, the release of a medicament can better meet physiological requirements and physiological rhythmicity, the tablet can be disintegrated in vivo quickly and is easy to absorb, the process is advanced, the process is clean, the investment is low, and the product quality can be better controlled to achieve a better effect.
Description
The technical field is as follows:
the invention belongs to the technical field of development of linolenic acid products, and particularly relates to α -linolenic acid double-layer tablets and a preparation method thereof.
Background art:
the planting area of flax in China is about 13.3 ten thousand square meters, the national yield is the highest, the annual yield is about 60 ten thousand tons, and the folded oil is about 15 ten thousand tons, the planting area of flax in the western part of China accounts for 71 percent of the whole country, the yield accounts for 94.9 percent of the whole country, flax resources in China are rich, flax seeds are mainly used for oil extraction and are most rich in various oils, wherein α -linolenic acid is an important component of the flax seed oil and is also the core of the value of the flax seed oil, but the flax seeds cannot play a sufficient role, the domestic polyunsaturated fatty acid market is gradually deepened, due to the difference of the living standard of people, the cognition on α -linolenic acid is generally insufficient, many people cannot even hear, and the comprehensive and scientific development is not performed, the effects of the α -linolenic acid products which can be seen at present are divided into two categories, namely, the effects of reducing blood fat, reducing blood pressure and preventing and treating cardiovascular and cerebrovascular diseases are the main effects, the intelligence is enhanced, the memory can be wide, the market prospect of the flax seeds can be widely regarded as a good and the health-care substance, and the daily health-care substance is required to be gradually expanded.
α -Linolenic Acid (Alpha-Linolenic Acid) called ALA for short, belonging to omega-3 series polyunsaturated fatty Acid, mainly existing in linseed oil and perilla seed oil, which are important components constituting human tissue cells experiments have proved that the deficiency of α -Linolenic Acid can cause the occurrence of symptoms such as amnesia, cancer, hyperlipemia, hypertension, diabetes, etc., especially the serious influence on the intelligence development of infants and children, which is proved by scientists at home and abroad and acknowledged by world nutriologists, α -Linolenic Acid also has obvious health care functions such as lowering blood pressure, improving memory, protecting intelligence, resisting cancer, etc., medical science also proves that 60% of human brain has specific fatty Acid composition, and only needs to synthesize DHA in vivo through α -Linolenic Acid to complete the brain development, therefore, α -has the reputation of "plant brain gold Linolenic Acid".
α -linolenic acid is the most scarce essential fatty acid in the food structure in China, experts in the medical and nutritional circles in China propose national legislation, promote and supplement α -linolenic acid which is essential in human dietary habits and is important to human bodies, and the α -linolenic acid is believed to have wider application prospects in the aspects of health care, medical treatment and the like along with the deep research on α -linolenic acid by people.
Because the α -linolenic acid molecule has three conjugated double bonds, so the molecular structure has very strong reducibility, and can be oxidized by oxygen, ultraviolet rays and some heavy metal ions in high temperature and air to cause the molecular structure to deteriorate, and the molecular structure has poor stability and cannot be really utilized by human bodies.
The invention content is as follows:
the technical problem to be solved by the invention is to provide the α -linolenic acid double-layer tablet and the preparation method thereof, so that the stability of α -linolenic acid is improved, the linolenic acid can be released to better meet physiological requirements and physiological rhythmicity, the product quality can be better controlled to achieve better nutritional effect, and better economic benefit and social benefit are created for human beings.
The α -linolenic acid double-layer tablet is characterized by comprising an inner layer and an outer layer, wherein the inner layer comprises an inner layer filler, an inner layer disintegrating agent, an inner layer adhesive, an inner layer lubricant and an inner layer absorbent, and the outer layer comprises an outer layer filler, an outer layer disintegrating agent, an outer layer adhesive and an outer layer lubricant.
Preferably, the inner layer comprises the following raw materials in parts by weight: 58-70% of inner layer filler, 1-3% of inner layer disintegrating agent, 15-20% of inner layer adhesive, 1-1.5% of inner layer lubricant and 15-20% of absorbent.
Preferably, the outer layer raw materials comprise, by weight, 72-83% of an outer layer filler, 4-8% of an outer layer disintegrating agent, 15-25% of an outer layer adhesive and 3-5% of an outer layer lubricant.
Preferably, the inner layer filler is α -linolenic acid, flaxseed gum, pregelatinized starch and microcrystalline cellulose, the inner layer disintegrant is crospovidone, the inner layer adhesive is 20% starch slurry, the inner layer lubricant is magnesium stearate and sodium dodecyl sulfate, and the absorbent is calcium hydrogen phosphate dihydrate.
Preferably, the inner layer filler comprises, by mass, α -linolenic acid 18-25%, flaxseed gum 20-25%, pregelatinized starch 5-9%, microcrystalline cellulose 5-9%, the inner layer disintegrant comprises, by mass, crospovidone 1-3%, the inner layer adhesive comprises 20% starch slurry 15-20%, the inner layer lubricant comprises, by mass, magnesium stearate 0.5-0.75%, sodium lauryl sulfate 0.5-0.75%, and the absorbent comprises calcium hydrogen phosphate dihydrate 15-20%.
Preferably, the outer layer filler is lactose, dextrin and mannitol, the outer layer disintegrating agent is crospovidone, the outer layer adhesive is 5% PEG-4000 aqueous solution, and the lubricant is magnesium stearate and sodium dodecyl sulfate.
Preferably, the outer layer filler comprises, by mass, 7-20% of lactose, 50-60% of dextrin and 5-6% of mannitol, the outer layer disintegrant comprises 4-8% of crospovidone, the outer layer binder comprises 15-25% of a 5% PEG-4000 aqueous solution, and the lubricant comprises 1-2% of magnesium stearate and 1-2% of sodium lauryl sulfate.
A preparation method of α -linolenic acid double-layer tablets comprises the following specific steps:
the first step is as follows: weighing inner layer raw materials according to the weight ratio of the inner layer raw materials: 72.5-83% of inner layer filler, 1-3% of inner layer disintegrating agent, 15-20% of inner layer adhesive, 1-1.5% of inner layer lubricant and 1-3% of absorbent;
the second step is that: pulverizing, and micronizing inner filler, inner disintegrating agent, inner binder, inner lubricant, and absorbent;
the third step: mixing, namely uniformly mixing the inner-layer filler, the inner-layer disintegrating agent and the absorbent after the superfine grinding in the second step;
the fourth step: granulating, adding the inner layer adhesive into the uniformly mixed mixture obtained in the third step to prepare a soft material, and sieving the soft material with a 16-mesh sieve to prepare granules;
the fifth step: drying, namely placing the granules prepared in the third step into a drying furnace, drying for 10-12 hours at 40-60 ℃, and grading in a 16-mesh sieve;
and a sixth step: mixing and tabletting: adding an inner lubricant into the granules after the granules are sized in the fourth step, uniformly mixing, and tabletting by using a tabletting machine to prepare an inner tabletting;
the seventh step: weighing outer layer raw materials according to the weight ratio of the outer layer raw materials: 72-83% of outer-layer filler, 4-8% of outer-layer disintegrating agent, 15-25% of outer-layer adhesive and 3-5% of outer-layer lubricant;
eighth step: pulverizing, and micronizing outer filler, outer disintegrating agent, outer adhesive, and outer lubricant respectively;
the ninth step: mixing and granulating, namely uniformly mixing the outer-layer filler, the outer-layer disintegrating agent and the outer-layer adhesive after the superfine grinding in the seventh step; making into soft material, sieving with 16 mesh sieve to obtain outer layer granule;
the tenth step: drying, namely putting the outer layer particles prepared in the eighth step into a drying furnace, drying for 10-12 hours at 40-60 ℃, and finishing the particles in a 16-mesh sieve;
and eleventh, mixing and tabletting, namely adding an outer layer lubricant into the outer layer granules after the granules are finished in the ninth step, putting the inner layer tablets into the outer layer granules for mixing, so that the outer layer granules are coated outside the inner layer tablets, and tabletting the inner layer tablets coated with the outer layer granules in a tabletting machine again to prepare α -linolenic acid double-layer tablets.
Preferably, the inner filler in the first step is α -linolenic acid, flaxseed gum, pregelatinized starch and microcrystalline cellulose, wherein the pregelatinized starch is weighed and added into water with the weight 1-1.5 times of the weight of the pregelatinized starch to prepare 20% starch slurry, and the prepared 20% starch slurry is added into boiling water to be continuously stirred and gelatinized.
Preferably, the outer layer adhesive in the sixth step is 5% PEG-4000 aqueous solution, wherein the weighed PEG-4000 is put into a beaker, and distilled water is added to the beaker to prepare the 5% PEG-4000 aqueous solution by continuous stirring.
The α -linolenic acid double-layer tablet has the beneficial effects that the α -linolenic acid double-layer tablet is prepared by adopting a method of wrapping an inner layer containing α -linolenic acid by an outer layer, the α -linolenic acid is absorbed by calcium hydrophosphate dihydrate, and the α -linolenic acid is solidified through flaxseed gum, pregelatinized starch and microcrystalline cellulose and then pressed into the tablet, so that the stability of the α -linolenic acid is improved, the release of a medicament can better meet the physiological requirement and the physiological rhythm, the tablet can be quickly disintegrated in vivo and easily absorbed, the process is advanced, the process is clean, the investment is small, and the product quality can be better controlled to achieve a better effect.
The specific implementation mode is as follows:
the first embodiment is as follows:
the α -linolenic acid double-layer tablet comprises an inner layer and an outer layer, wherein the inner layer comprises α -linolenic acid 20 wt%, flaxseed gum 20 wt%, pre-crosslinked starch 9 wt%, microcrystalline cellulose 9 wt%, crospovidone 1 wt%, 20% starch slurry 15 wt%, magnesium stearate 0.5 wt%, sodium lauryl sulfate 0.5 wt%, calcium hydrogen phosphate dihydrate 15 wt%, and the outer layer comprises lactose 20 wt%, dextrin 58 wt%, mannitol 5 wt%, crospovidone 4 wt%, 5% PEG-4000 water solution 15 wt%, magnesium stearate 1 wt%, and sodium lauryl sulfate 1 wt%.
A preparation method of α -linolenic acid double-layer tablets comprises the following specific steps:
the first step is that inner layer raw materials are weighed, wherein the inner layer raw materials comprise α -linolenic acid 20%, flaxseed gum 20%, pre-crosslinked starch 9%, microcrystalline cellulose 9%, crospovidone 1%, 20% starch slurry 15%, magnesium stearate 0.5%, sodium dodecyl sulfate 0.5% and calcium hydrogen phosphate dihydrate 15% according to the weight ratio, wherein the weighed pre-gelatinized starch is placed in water with the weight of 1-1.5 times of the weight of the pre-gelatinized starch to prepare 20% starch slurry, the prepared 20% starch slurry is placed in boiling water to be continuously stirred and gelatinized, the weighed PEG-4000 is placed in a beaker, and distilled water is added to be continuously stirred to prepare 5% PEG-4000 aqueous solution.
The second step is that: pulverizing pregelatinized starch, microcrystalline cellulose, polyvinylpolypyrrolidone, 20% starch slurry, magnesium stearate, sodium lauryl sulfate, and calcium hydrogen phosphate dihydrate by micronizing respectively;
mixing, namely uniformly mixing α -linolenic acid, flaxseed gum, pregelatinized starch, microcrystalline cellulose, crospovidone and calcium hydrophosphate dihydrate which are subjected to superfine grinding in the second step, and solidifying the α -linolenic acid by the flaxseed gum, the pregelatinized starch and the microcrystalline cellulose after the calcium hydrophosphate dihydrate absorbs the linolenic acid;
the fourth step: granulating, adding 20% starch slurry into the mixture uniformly mixed in the third step to prepare a soft material, and sieving with a 16-mesh sieve to prepare inner-layer granules;
the fifth step: drying, namely placing the inner-layer particles prepared in the third step into a drying furnace, drying for 10-12 hours at 40-60 ℃, and grading in a 16-mesh sieve;
and a sixth step: mixing and tabletting: adding the magnesium stearate and the sodium dodecyl sulfate in the inner layer into the inner layer granules after the granules are granulated in the fourth step, uniformly mixing, and tabletting by using a tabletting machine to prepare inner layer tablets;
the seventh step: weighing outer layer raw materials according to the weight ratio of the inner layer raw materials: 20% of lactose, 58% of dextrin, 5% of mannitol, 4% of crospovidone, 15% of 5% PEG-4000 aqueous solution, 2% of magnesium stearate and 1% of sodium dodecyl sulfate;
eighth step: pulverizing, and micronizing lactose, dextrin, mannitol, polyvinylpolypyrrolidone, 5% PEG-4000 water solution, magnesium stearate, pulvis Talci, and sodium laurylsulfate respectively;
the ninth step: mixing and granulating, namely uniformly mixing the lactose, the dextrin, the mannitol, the crospovidone and the 5% PEG-4000 aqueous solution after the superfine grinding in the seventh step; making into soft material, sieving with 16 mesh sieve to obtain outer layer granule;
the tenth step: drying, namely putting the outer-layer particles prepared in the eighth step into a drying furnace, drying for 12 hours at 40 ℃, and finishing the particles in a 16-mesh sieve;
and eleventh, mixing and tabletting, namely adding magnesium stearate and sodium dodecyl sulfate into the granulated outer layer granules obtained in the ninth step, putting the inner layer tablets into the outer layer granules for mixing, so that the outer layer granules are coated outside the inner layer tablets, and tabletting the inner layer tablets coated with the outer layer granules in a tabletting machine again to obtain the α -linolenic acid double-layer tablets.
Example two:
the α -linolenic acid double-layer tablet comprises an inner layer and an outer layer, wherein the inner layer comprises α -linolenic acid 18 wt%, flaxseed gum 22 wt%, pre-crosslinked starch 6 wt%, microcrystalline cellulose 6 wt%, crospovidone 2 wt%, 20% starch slurry 17.8 wt%, magnesium stearate 0.6 wt%, sodium lauryl sulfate 0.6 wt%, and calcium hydrogen phosphate dihydrate 18 wt%, and the outer layer comprises lactose 15 wt%, dextrin 50 wt%, mannitol 5 wt%, crospovidone 6 wt%, 5% PEG-4000 water solution 20 wt%, magnesium stearate 2 wt%, and sodium lauryl sulfate 2 wt%.
A preparation method of α -linolenic acid double-layer tablets comprises the following specific steps:
the first step is that inner layer raw materials are weighed, wherein the inner layer raw materials comprise, by weight, α -linolenic acid 18%, flaxseed gum 22%, pre-crosslinked starch 6%, microcrystalline cellulose 6%, crospovidone 2%, 20% starch slurry 17.8%, magnesium stearate 0.6%, sodium dodecyl sulfate 0.6% and calcium hydrophosphate dihydrate 18%, wherein the weighed pre-gelatinized starch is added into water 1-1.5 times of the weight of the pre-gelatinized starch to prepare 20% starch slurry, the prepared 20% starch slurry is added into boiling water to be continuously stirred and gelatinized, the weighed PEG-4000 is placed into a beaker, and distilled water is added to be continuously stirred to prepare a 5% PEG-4000 aqueous solution.
The second step is that: pulverizing pregelatinized starch, microcrystalline cellulose, polyvinylpolypyrrolidone, 20% starch slurry, magnesium stearate, sodium lauryl sulfate, and calcium hydrogen phosphate dihydrate by micronizing respectively;
thirdly, mixing, namely evenly mixing the α -linolenic acid, the pregelatinized starch, the microcrystalline cellulose, the crospovidone and the calcium hydrophosphate dihydrate which are subjected to superfine grinding in the second step, wherein the α -linolenic acid is absorbed by the calcium hydrophosphate dihydrate and then is solidified by the flaxseed gum, the pregelatinized starch and the microcrystalline cellulose;
the fourth step: granulating, adding 20% starch slurry into the mixture uniformly mixed in the third step to prepare a soft material, and sieving with a 16-mesh sieve to prepare inner-layer granules;
the fifth step: drying, namely placing the inner-layer particles prepared in the third step into a drying furnace, drying for 10-12 hours at 40-60 ℃, and grading in a 16-mesh sieve;
and a sixth step: mixing and tabletting: adding the magnesium stearate and the sodium dodecyl sulfate in the inner layer into the inner layer granules after the granules are granulated in the fourth step, uniformly mixing, and tabletting by using a tabletting machine to prepare inner layer tablets;
the seventh step: weighing outer layer raw materials according to the weight ratio of the outer layer raw materials: 15% of lactose, 50% of dextrin, 5% of mannitol, 6% of crospovidone, 20% of 5% PEG-4000 aqueous solution, 2% of magnesium stearate and 2% of sodium dodecyl sulfate;
eighth step: pulverizing, and micronizing lactose, dextrin, mannitol, polyvinylpolypyrrolidone, 5% PEG-4000 water solution, magnesium stearate, pulvis Talci, and sodium laurylsulfate respectively;
the ninth step: mixing and granulating, namely uniformly mixing the lactose, the dextrin, the mannitol, the crospovidone and the 5% PEG-4000 aqueous solution after the superfine grinding in the seventh step; making into soft material, sieving with 16 mesh sieve to obtain outer layer granule;
the tenth step: drying, namely putting the outer-layer particles prepared in the eighth step into a drying furnace, drying for 11 hours at 50 ℃, and finishing the particles in a 16-mesh sieve;
and eleventh, mixing and tabletting, namely adding magnesium stearate and sodium dodecyl sulfate into the granulated outer layer granules obtained in the ninth step, putting the inner layer tablets into the outer layer granules for mixing, so that the outer layer granules are coated outside the inner layer tablets, and tabletting the inner layer tablets coated with the outer layer granules in a tabletting machine again to obtain the α -linolenic acid double-layer tablets.
Example three:
the α -linolenic acid double-layer tablet comprises an inner layer and an outer layer, wherein the inner layer comprises α -linolenic acid 25 wt%, flaxseed gum 25 wt%, pre-crosslinked starch 5 wt%, microcrystalline cellulose 5 wt%, crospovidone 3 wt%, 20% starch slurry 20 wt%, magnesium stearate 0.75 wt%, sodium lauryl sulfate 0.75 wt%, and calcium hydrogen phosphate dihydrate 20 wt%, and the outer layer comprises lactose 7 wt%, dextrin 60 wt%, mannitol 5 wt%, crospovidone 8 wt%, 5% PEG-4000 aqueous solution 25 wt%, magnesium stearate 1 wt%, and sodium lauryl sulfate 2 wt%.
A preparation method of α -linolenic acid double-layer tablets comprises the following specific steps:
the first step is that inner layer raw materials are weighed, wherein α -linolenic acid 25%, flax gum 25%, pre-crosslinked starch 5%, microcrystalline cellulose 5%, crospovidone 3%, 20% starch slurry 20%, magnesium stearate 0.75%, sodium dodecyl sulfate 0.75% and calcium hydrogen phosphate dihydrate 20% are mixed according to the weight ratio of the inner layer raw materials, wherein the weighed pre-gelatinized starch is added into water with the weight of 1-1.5 times of the weight of the pre-gelatinized starch to prepare 20% starch slurry, the prepared 20% starch slurry is added into boiling water to be continuously stirred and gelatinized, the weighed PEG-4000 is put into a beaker, and distilled water is added to be continuously stirred to prepare 5% PEG-4000 aqueous solution;
the second step is that: pulverizing pregelatinized starch, microcrystalline cellulose, polyvinylpolypyrrolidone, 20% starch slurry, magnesium stearate, sodium lauryl sulfate, and calcium hydrogen phosphate dihydrate by micronizing respectively;
mixing, namely uniformly mixing α -linolenic acid, flaxseed gum, pregelatinized starch, microcrystalline cellulose, crospovidone and calcium hydrophosphate dihydrate which are subjected to superfine grinding in the second step, and solidifying the α -linolenic acid by the flaxseed gum, the pregelatinized starch and the microcrystalline cellulose after the calcium hydrophosphate dihydrate absorbs the linolenic acid;
the fourth step: granulating, adding 20% starch slurry into the mixture uniformly mixed in the third step to prepare a soft material, and sieving with a 16-mesh sieve to prepare inner-layer granules;
the fifth step: drying, namely placing the inner-layer particles prepared in the third step into a drying furnace, drying for 10 hours at 60 ℃, and grading in a 16-mesh sieve;
and a sixth step: mixing and tabletting: adding the magnesium stearate and the sodium dodecyl sulfate in the inner layer into the inner layer granules after the granules are granulated in the fourth step, uniformly mixing, and tabletting by using a tabletting machine to prepare inner layer tablets;
the seventh step: weighing outer layer raw materials according to the weight ratio of the outer layer raw materials: 7% of lactose, 60% of dextrin, 5% of mannitol, 8% of crospovidone, 25% of 5% PEG-4000 aqueous solution, 3% of magnesium stearate and 2% of sodium dodecyl sulfate;
eighth step: pulverizing, and respectively micronizing lactose, dextrin, mannitol, polyvinylpolypyrrolidone, 5% PEG-4000 water solution, magnesium stearate, and sodium laurylsulfate;
the ninth step: mixing and granulating, namely uniformly mixing the lactose, the dextrin, the mannitol, the crospovidone and the 5% PEG-4000 aqueous solution after the superfine grinding in the seventh step; making into soft material, sieving with 16 mesh sieve to obtain outer layer granule;
the tenth step: drying, namely putting the outer-layer particles prepared in the eighth step into a drying furnace, drying for 11 hours at 50 ℃, and finishing the particles in a 16-mesh sieve;
and eleventh, mixing and tabletting, namely adding magnesium stearate, talcum powder and sodium dodecyl sulfate into the granulated outer layer granules obtained in the ninth step, putting the inner layer tablets into the outer layer granules, mixing to enable the outer layer granules to be coated outside the inner layer tablets, and tabletting the inner layer tablets coated with the outer layer granules in a tabletting machine again to obtain the α -linolenic acid double-layer tablets.
The results of the α -linolenic acid bilayer tablet stability test from the above examples are as follows:
(1) high temperature test result
As can be seen from Table 1, after being packaged in an aluminum foil bag and stored for 15 days under high temperature conditions, the appearance, the weight difference and the α -linolenic acid content are not obviously changed, and the hardness and the disintegration time limit meet the quality standards of tablets.
TABLE 1 high temperature test results
(2) High humidity experiment detection result
As can be seen from Table 2, after being packaged in aluminum foil bags, the tablets are stored for 15 days under high humidity conditions, have no moisture absorption phenomenon, have no obvious changes in appearance, weight difference and α -linolenic acid content, and have hardness and disintegration time which meet the quality standards of the tablets.
Table 2 high humidity test results
(3) Test result of illumination experiment
As can be seen from Table 3, after being packaged in aluminum foil bags and stored for 15 days under the illumination condition (4500LX +/-500 LX), the appearance, the weight difference and the α -linolenic acid content are not obviously changed, and the hardness and the disintegration time limit meet the quality standard of the tablets.
TABLE 3 test results of the light test
The present invention is not limited to the above-described embodiments, and those skilled in the art will be able to make various modifications without creative efforts from the above-described conception, and fall within the scope of the present invention.
Claims (10)
1. The α -linolenic acid double-layer tablet is characterized by comprising an inner layer and an outer layer, wherein the inner layer comprises an inner layer filler, an inner layer disintegrating agent, an inner layer adhesive, an inner layer lubricant and an inner layer absorbent, and the outer layer comprises an outer layer filler, an outer layer disintegrating agent, an outer layer adhesive and an outer layer lubricant.
2. The α -linolenic acid double-layer tablet according to claim 1, characterized in that the weight ratio of the inner layer raw materials is 58-70% of inner layer filler, 1-3% of inner layer disintegrating agent, 15-20% of inner layer adhesive, 1-1.5% of inner layer lubricant and 15-20% of absorbent.
3. The α -linolenic acid double-layer tablet of claim 1, wherein the outer layer comprises 72-83% of outer layer filler, 4-8% of outer layer disintegrating agent, 15-25% of outer layer adhesive and 3-5% of outer layer lubricant.
4. The α -linolenic acid bilayer tablet of claim 1 or 2, wherein the inner layer filler is α -linolenic acid, flaxseed gum, pregelatinized starch, microcrystalline cellulose, the inner layer disintegrant is crospovidone, the inner layer binder is 20% starch slurry, the inner layer lubricant is magnesium stearate and sodium lauryl sulfate, and the absorbent is calcium hydrogen phosphate dihydrate.
5. The α -linolenic acid bilayer tablet of claim 4, wherein the inner layer filler comprises, by mass, 18% -25% of α -linolenic acid, 20% -25% of flaxseed gum, 5% -9% of pregelatinized starch, 5% -9% of microcrystalline cellulose, 1% -3% of crospovidone as an inner layer disintegrant, 15% -20% of starch slurry as an inner layer binder, 0.5% -0.75% of magnesium stearate, 0.5% -0.75% of sodium lauryl sulfate as an inner layer lubricant, and 15% -20% of calcium hydrogen phosphate dihydrate as an absorbent.
6. The α -linolenic acid bilayer tablet of claim 1 or 2, wherein the outer layer filler is lactose, dextrin, and mannitol, the outer layer disintegrant is crospovidone, the outer layer binder is 5% PEG-4000 aqueous solution, and the lubricant is magnesium stearate and sodium dodecyl sulfate.
7. The α -linolenic acid bilayer tablet of claim 6, wherein the outer layer filler comprises, by mass, 7% -20% of lactose, 50% -60% of dextrin, and 5% -6% of mannitol, the outer layer disintegrant comprises, by mass, 4% -8% of crospovidone, the outer layer binder comprises, by mass, 15% -25% of a 5% PEG-4000 aqueous solution, and the lubricant comprises, by mass, 1% -2% of magnesium stearate and 1% -2% of sodium lauryl sulfate.
8. The preparation method of the α -linolenic acid double-layer tablet is characterized by comprising the following specific preparation steps:
the first step is as follows: weighing inner layer raw materials according to the weight ratio of the inner layer raw materials: 72.5-83% of inner layer filler, 1-3% of inner layer disintegrating agent, 15-20% of inner layer adhesive, 1-1.5% of inner layer lubricant and 1-3% of absorbent;
the second step is that: pulverizing, and micronizing inner filler, inner disintegrating agent, inner binder, inner lubricant, and absorbent;
the third step: mixing, namely uniformly mixing the inner-layer filler, the inner-layer disintegrating agent and the absorbent after the superfine grinding in the second step;
the fourth step: granulating, adding the inner layer adhesive into the uniformly mixed mixture obtained in the third step to prepare a soft material, and sieving the soft material with a 16-mesh sieve to prepare granules;
the fifth step: drying, namely placing the granules prepared in the third step into a drying furnace, drying for 10-12 hours at 40-60 ℃, and grading in a 16-mesh sieve;
and a sixth step: mixing and tabletting: adding an inner lubricant into the granules after the granules are sized in the fourth step, uniformly mixing, and tabletting by using a tabletting machine to prepare an inner tabletting;
the seventh step: weighing outer layer raw materials according to the weight ratio of the outer layer raw materials: 72-83% of outer-layer filler, 4-8% of outer-layer disintegrating agent, 15-25% of outer-layer adhesive and 3-5% of outer-layer lubricant;
eighth step: pulverizing, and micronizing outer filler, outer disintegrating agent, outer adhesive, and outer lubricant respectively;
the ninth step: mixing and granulating, namely uniformly mixing the outer-layer filler, the outer-layer disintegrating agent and the outer-layer adhesive after the superfine grinding in the seventh step; making into soft material, sieving with 16 mesh sieve to obtain outer layer granule;
the tenth step: drying, namely putting the outer layer particles prepared in the eighth step into a drying furnace, drying for 10-12 hours at 40-60 ℃, and finishing the particles in a 16-mesh sieve;
and eleventh, mixing and tabletting, namely adding an outer layer lubricant into the outer layer granules after the granules are finished in the ninth step, putting the inner layer tablets into the outer layer granules for mixing, so that the outer layer granules are coated outside the inner layer tablets, and tabletting the inner layer tablets coated with the outer layer granules in a tabletting machine again to prepare α -linolenic acid double-layer tablets.
9. The method for preparing α -linolenic acid bilayer tablet according to claim 8, wherein the inner layer filler in the first step is α -linolenic acid, flax gum, pregelatinized starch, microcrystalline cellulose, wherein the pregelatinized starch is prepared by adding the weighed pregelatinized starch into water 1-1.5 times of the weight of the pregelatinized starch to prepare 20% starch slurry, and the prepared 20% starch slurry is added into boiling water to be stirred and gelatinized continuously.
10. The method for preparing α -linolenic acid bilayer tablet according to claim 8, wherein the outer layer binder in the sixth step is 5% PEG-4000 aqueous solution, wherein the 5% PEG-4000 aqueous solution is prepared by adding the weighed PEG-4000 into a beaker and adding distilled water under stirring.
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